Biphasic anaphylaxis after first dose of messenger RNA coronavirus disease 2019 vaccine with positive polysorbate 80 skin testing result

Anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines: a systematic review and meta-analysis

“…The detailed characteristics of the included studies are shown in Tables 1 and 2 . Among the included studies, 12 reported anaphylaxis reactions [ 22 , 25 , 27 , 29 , 33 – 36 , 38 – 40 ], 17 reported nonanaphylactic reactions [ 18 – 24 , 26 – 28 , 30 – 32 , 35 , 37 , 39 , 41 ], and 3 studies reported both anaphylactic and nonanaphylactic reactions ( 27 , 35 , 40 ). The majority of studies reporting incidence rates of anaphylaxis and nonanaphylactic reactions were conducted based on registry databases [ 22 , 24 , 30 , 33 , 39 , 40 ], and most were from hospital and/or emergency department admission databases [ 18 , 19 , 21 – 23 , 25 – 28 , 30 – 36 , 38 – 41 ].…”

“…These studies were conducted in United States (n = 15), Italy (n = 3), United Kingdom (n = 2), Canada (n = 1), France (n = 1), South Korea (n = 1), Spain (n = 1), Portugal (n = 1), and Czech Republic (n = 1). Only 3 studies were performed with a multi-centre design [ 19 , 22 , 35 ]. The median NOS score for these studies was 6 (range, 5–7).…”

“…Five and three studies exclusively reported anaphylaxis events in vaccine recipients of Pfizer-BioNTech [ 25 , 34 , 36 , 38 , 39 ] and Moderna [ 27 , 35 , 39 ], respectively; and four studies reported on anaphylactic reactions after the administration of both mRNA vaccines [ 22 , 29 , 33 , 40 ]. Nonanaphylactic reactions were reported in patients after receiving Pfizer-BioNTech [ 18 , 20 , 21 , 23 , 24 , 32 , 37 , 41 ] or Moderna [ 19 , 22 , 26 , 27 , 31 , 39 ]; and few studies reported on nonanaphylactic reactions due to the vaccination by both COVID-19 vaccines [ 28 , 30 , 35 ].…”

“…No death from anaphylaxis was reported Yes. [Not reported]; and patient showed no reactions to intradermal PEG, polysorbate 80 and Pfizer-BioNTech vaccine (NOS; 6) Serum tryptase level was within reference range (4.7 μg/L and 5.4 μg/L) Cholinergic urticaria was confirmed via exercise provocation challenge guided by a standardized protocol (53) Patient tolerated a second dose of Pfizer-BioNTech vaccine, without premedication, exhibiting only transient, mild nausea and a sense of warmth Pitlick et al 2021 [ 35 ], United States Retrospective case reports, multicenter 22-year-old female 0 (0) Allergic rhinitis Patient reported no prior history of anaphylaxis Moderna, dose 1 20 min Angioedema, wheezing, and throat pruritus Case was classified as Brighton Level 1 a Not measured Patient was treated in the ED and given antihistamines and steroids 0 (0) Patient recovered with complete resolution of the suspected adverse drug reaction. No death from anaphylaxis was reported Yes.…”

“…dexchlorpheniramine 0 (0) Patient recovered with complete resolution of the suspected adverse drug reaction Yes. [Not reported]; and SPT in patient was not allergic to PEG-3350 RoB 2; some concerns risk of bias No modification on tryptase levels compared with the baseline was found Pitlick et al 2021 [ 35 ], United States Retrospective case reports, multicenter Median (IQR), 36 (24–52) 2 (28.6) About 4 (57.1%) of the cases had prior drug (influenza vaccine and antihistamines) and food allergy; and asthma. However, two (28.6%) cases had no allergy history Two (28.6%) cases had prior insect stinging (venom) anaphylaxis Pfizer-BioNTech (n = 6) AND Moderna (n = 1); both brands after dose 1 Median [range], 97 [6–405] Urticaria, tachycardia, rhinorrhea, facial flushing, oral pruritus, throat fullness and tightness, and angioedema Patients were treated at the vaccination sites and given antihistamines and steroids – Patient recovered with complete resolution of the suspected adverse drug reaction.…”